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At least 289 records · Page 16Linked to original sources
PubMed2003

Conversion from a non-indwelling to a Provox2 indwelling voice prosthesis for speech rehabilitation: comparison of voice quality and patient preference.

This prospective study assessed the advantages and problems associated with converting a patient using an older generation non-indwelling voice prosthesis to a newer generation indwelling voice prosthesis, in this case the Provox2. The voice characteristics of each patient were measured using the old and then the new voice prosthesis. Technical aspects of the insertion of the indwelling prosthesis were noted. Each patient completed a questionnaire after a period of use with the indwelling prosthesis. Changing the prosthesis was simple and uncomplicated in 15 of 17 patients. Acoustic analysis showed improved parameters with the indwelling prosthesis, but no perceptual difference between the two prostheses. The questionnaire revealed that most patients preferred the indwelling prosthesis. Replacing a non-indwelling with an indwelling prosthesis is technically simple, leading to improvement in voice quality and patient satisfaction. It may be reasonable to offer this choice to patients currently using an older generation non-indwelling voice prosthesis.

Aged↗
PubMed2005

[Speech rehabilitation using Provox voice prosthesis].

The first voice prosthesis was described in 1972 by Mozolewski. Eight years later Blom and Singer constructed the first commercial prosthesis. In 1988 another prosthesis was presented as Provox system prosthesis. The aim of the study was to describe the technique of tracheoesophageal puncture (TEP) and to present two years results of the technique performed in 21 patients. Primary TEP with immediate implantation of the Provox 2 prosthesis was applied in 16 (76%) patients. In five patients (24%) secondary TEP was performed. All the patient with primary TEP had cricopharyngeal myotomy. In 7 patients the vocal prosthesis was exchanged. In five because of leakage through the valve and in two patients the vocal prosthesis was extruded. Leakage around the prosthesis occurred in two patients with secondary TEP. The mean device-related lifetime was 216 days and ranged from 30 to 540 days. In non-radiated patients the lifetime of the prosthesis was 255 days and in patients after radiotherapy the lifetime was 150 days. In all the patients the prosthetic voice was more similar to normal voice than in patients with esophageal speech. The implantation of the voice prosthesis is a simple method of restoring of a good quality voice enabling communication.

Adult↗
PubMed1993

A compliant biological vascular prosthesis.

One requirement of the mechanical parameters for an acceptable vascular prosthesis is compliance. The compliance of a vascular prosthesis is defined as the fractional change in luminal volume per unit change in applied pressure. A compliant prosthesis has been correlated to prosthesis patency and long-term efficacy in an animal study. However, there have been very few reports on how to manufacture a compliant prosthesis. It is the objective of this study to research the processing methods to manufacture a reasonably compliant vascular prosthesis. A new fixative, polyepoxy compound, was used to fix an artery. The arteries were fixed under different degrees of longitudinal retraction. By locking in the collagen micro-structure at an overly relaxed state and then crosslinking said collagen, the resulting biological prosthesis exhibited extreme compliance and pliability. A prosthesis matching its arterial origin in tensile modulus was achieved by crosslinking an artery at its 45% retraction longitudinally. This flexible prosthesis showed a volumetric compliance index of 18.4 +/- 0.9 % delta/100 mmHg and a longitudinal tensile modulus of 942 grams/cm2. Our current study indicated that a prosthesis fixed with polyepoxy compounds has shown more pliability than that with glutaraldehyde. Further animal study to correlate prostheses patency to different degrees of compliance is needed to confirm this proposed manufacturing approach.

Bioprosthesis↗
PubMed2001

Measurement of the migration of a cemented hip prosthesis in an in vitro test.

OBJECTIVE: To develop a method to measure the migration of a cemented hip prosthesis in an in vitro experimental test. DESIGN: A device to measure prosthesis movement relative to bone was designed and fabricated. It was tested using a Lubinus prosthesis (W. Link, Germany) implanted in a composite femur. BACKGROUND: Clinical studies using radiostereophotogrammetry have shown that those cemented hip prosthesis that migrate rapidly in the first two post-operative years are the ones that require early revision. If migration be used as a basis for a pre-clinical test, then it should be possible to screen-out inferior designs before implantation in animal or clinical trials. METHODS: The micromotion measurement device consisted of a 'target' of three spheres arranged in a cruciform structure. Six linear variable displacement transducers were aligned with the spheres so that motion of the prosthesis relative to the bone could be measured. RESULTS: The displacement and rotation of the prosthesis relative to the composite femur was recorded for two million cycles. Relative rapid initial migration was found, followed by a period of steady-state migration. Distal migration (called 'subsidence' in this paper) of up to 0.1 mm was measured; however the variability in absolute prosthesis migration was very high despite efforts to ensure that all extraneous factors were minimised. In the majority of cases, the prostheses migrated medially, distally and anteriorly. The absolute subsidence, and its variability, were similar to that recorded clinically. CONCLUSIONS: A method has been designed and tested which measures prosthesis migration in an experimental test. It provides a basis for a pre-clinical testing standard. Relevance. Hip prostheses need to be tested experimentally before implantation. However, no reliable test exists for such experimental tests. Rapid migration of a cemented prosthesis relative to bone has been shown in vivo to correlate with early failure, and in this paper a method to make such migration measurements in vitro is described and tested.

Cementation↗
PubMed1997

Lower extremity residual limb slippage within the prosthesis.

OBJECTIVE: The ability to measure skin surface slippage relative to the internal wall of a lower extremity prosthesis under various loading conditions is important for evaluation of socket fit and function, and creation of finite element models. Skin surface three-dimensional (3D) shape measurements with tracking of fiducial displacements in situ under axial loading of the prosthesis have not previously been reported. Analysis of slippage within the prosthesis has been performed using a new experimental measurement method based on spiral x-ray computed tomography (SXCT) imaging. DESIGN: Small lead markers were placed on the residuum of an adult with a below-knee amputation, and SXCT scans were obtained with the prosthesis in situ under two static axial loading conditions (44.5N and 178N). The 3D scan data were used to assess slippage with three methods: gross displacement of the tibia and distal end of the residuum; relative displacement of markers; and distance measurements between markers. RESULTS: The markers affixed to the below-knee skin surface within the prosthesis were measured. The skin slipped from 2 to 6 mm relative to the internal prosthesis wall when an additional load of 133.5N was applied in the axial direction to the distal end of the prosthesis. The tibial remnant moved 10.0 mm distally relative to the prosthesis internal wall. CONCLUSION: This method provides a feasible means for measuring residuum skin slippage relative to the prosthesis and skin deformation relative to tibia within an in situ prosthesis under load.

Artificial Limbs↗
PubMed2001

Conventional or adhesive external breast prosthesis? A prospective study of the patients' preference after mastectomy.

After having been subjected to radical mastectomy for breast cancer, women are usually fitted with an external breast prosthesis. Different types of prostheses are available, but oncology nurses have few data enabling them to advise their patients adequately. In this prospective randomized crossover study of 101 women undergoing one-sided mastectomy for breast cancer, the self-adhesive breast prosthesis was compared with the traditional external prosthesis. Questionnaires were used to evaluate the woman's judgment of the prosthesis in relation to her final preference for one type of prosthesis. Complete data were available for 91 women, 59.3% of whom finally preferred the self-adhesive type. Preference was independent of age, randomization, order, or the possible use of adjuvant chemotherapy. Satisfaction with the self-adhesive prosthesis was independent of randomization order but satisfaction with the traditional type was significantly more when it was the first type of prosthesis. Preference for the self-adhesive prosthesis over the traditional type mas mainly related to an increased perception of the prosthesis as a part of the body. Preference for the traditional prosthesis over the other type was mainly related to the greater ease of application and the lesser local irritation of the skin. Findings from this study can be useful in oncology nursing practice.

Adhesives↗
PubMed1994

[Clinical application of AW glass ceramic prosthesis in spinal surgery].

Bone prosthesis of apatite- and wollastonite-containing glass-ceramic (AW-GC), a new synthesized material, is known to be excellent in bonding directly with adjacent living bone tissue, in having strong mechanical strength and no toxic effects, in experimental studies. In spinal surgery, massive and strong bone grafts are required for reconstruction of the spinal column affected by a tumor, trauma, or a degenerative disease. However, utilization of bone allograft is not yet socially accepted in Japan and also there are other barriers against the supply of allograft bone. In the present study, AW-GC bone prosthesis was used for reconstructive surgery for various spinal diseases and follow-up studies were performed for an average of 14.9 months (range: 2-36 mo). The clinical results were satisfactory. Thirty patients (males: 17 and females: 13) with an age range of 40-75 years (mean: 55.3 years) were reviewed in this study. Preoperative diagnoses for which an AW-GC prosthesis was required were as follows; vertebral prosthesis: 15 with metastatic tumor of the spine, 3 with burst fracture of the thoraco-lumbar spine; vertebral spacer: 6 with degenerative spondylolisthesis, 2 with isthmic spondylolisthesis, 2 with lumbar intervertebral disc herniation, and one with spinal canal stenosis. Patient's satisfaction, roentgenographic evaluation, laboratory data on blood and urine, and toxic effects were examined in these patients. As a result, the patient's satisfaction for the AW-GC bone prosthesis was high, and the initial fixation and long term stability were excellent. For kyphotic deformity and scoliosis, postoperative correction could be maintained in two patients where correction was attempted, and the usefulness of AW-GC prosthesis as a spinal prosthesis was confirmed. Good bone formation around the prosthesis was observed with time. The clear zone (radiolucent line between ceramic and bone) tended to decrease or disappear. There were no systemic or local toxic side-effects considered to be due to the AW-GC bone prosthesis, or no abnormalities in the laboratory data. These findings suggested that the AW-GC bone prosthesis is a new biomaterial with excellent properties which can be successfully substituted for bone graft in reconstructive spinal surgery.

Adult↗
PubMed1997

Early speech results with the Provox prosthesis after laryngectomy.

OBJECTIVES: To assess our initial success using the Provox (Atos Medical AB, Horby, Sweden, and Entermad BV, Woerden, the Netherlands) tracheoesophageal speaking valve as the primary prosthesis to rehabilitate patients after total laryngectomy and to compare our success and complication rates with those previously reported. DESIGN: A retrospective analysis of all the patients who had a Provox prosthesis placed from November 1994 to November 1995. PATIENTS AND METHODS: Medical charts were reviewed for success or failure of the prosthesis as determined by the quality of speech and the utility of the device. In addition, complications, whether the patient had a pharyngeal myotomy and/or radiation, and the reasons and timing for replacement were assessed. Twenty-one patients had a Provox prosthesis placed either primarily at the time of their total laryngectomy (n = 8), delayed (n = 5), or as a replacement for another type of prosthesis (n = 8). Follow-up ranged from 2 to 17 months. RESULTS: The initial success rate was 84%, and the long-term success rate was 74%. Of note, 3 patients had substantially improved speech and none were worse when changed from another type of prosthesis. The mean interval to prosthesis change was 166 days. Reasons for failure included infection, radiation fibrosis, manual incoordination, cerebrovascular accident, and combination of total laryngectomy and total glossectomy. The most common complication (in 2 patients) was retraction of the prosthesis into the esophagus that was successfully managed by replacement with a longer device. CONCLUSION: Our early results confirm the effectiveness, longevity, and safety of the Provox prosthesis for speech rehabilitation following total laryngectomy.

Adult↗
PubMed1986

Transfemoral placement of intraluminal polyurethane prosthesis for abdominal aortic aneurysm.

Because of the significant mortality associated with the conventional surgical approach to abdominal aortic aneurysms (AAA) in the high risk patients and in those with ruptured aneurysms, we have developed a new approach to this problem, intraluminal aneurysm exclusion. This was achieved by an intraluminal prosthesis which approximated the diameter of the aorta above and below the aneurysm and is inserted through the femoral artery. The prosthesis consisted of biomedical grade elastomeric polyurethane with a NITINOL and/or stainless steel frame and was designed in such a configuration that it could be compressed inside a 15 F catheter and then regain its original shape after being discharged inside the aorta. The polyurethane prosthesis tolerated static pressures in excess of 300 Torr. Aneurysmal aortas were created in three adult sheep using large knitted Dacron pathches (6 X 9 cm) sewn onto a longitudinal aortotomy. After 4-6 weeks, an intraluminal prosthesis was passed transfemorally to the location of the aortic aneurysm. Following satisfactory placement and expansion of the prosthesis, a laceration was produced in the aneurysmal wall. No bleeding developed, which confirmed the integrity of the prosthesis in excluding the aneurysm from the aorta proper. Pulsation in the iliac arteries indicated the presence of aortic blood flow through the prosthesis. Autopsy examination demonstrated directly that the prosthesis was open and that its two ends were fixed in the aorta above and below the aneurysm. The study has demonstrated that intraluminal AAA exclusion could be achieved with an intraluminal polyurethane prosthesis inserted through the femoral artery.

Animals↗
PubMed2003

Long-term results of VoiceMaster voice prosthesis use in laryngectomized patients.

OBJECTIVE: To report on the long-term results, focusing on prosthesis lifetime, achieved with the VoiceMaster prosthesis in an outpatient population. MATERIAL AND METHODS: The VoiceMaster prosthesis was used over a 40-month period. Average prosthesis lifetimes were calculated both individually and for the group as a whole. Factors determining prosthesis insertion were noted. Also, the possible effect of interim prosthesis cleaning and reinsertion of the same device, a specific VoiceMaster characteristic, was assessed. RESULTS: An average prosthesis lifetime of 6.5 months was attained for the whole patient group and several devices were still in situ at the end of the 40-month period. Local factors (tracheostoma size, fistula position and characteristics) influence insertion. Interim cleaning with immediate reinsertion of the device can greatly enhance prosthesis lifetime on an individual basis. CONCLUSIONS: The attained average prosthesis lifetime demonstrates that the VoiceMaster merits a place within the array of available prostheses used in post-laryngectomy outpatient voice rehabilitation.

Female↗
PubMed1999

Metal-on-metal bearing in hip prosthesis generates 100-fold less wear debris than metal-on-polyethylene.

Aseptic loosening due to osteolysis in total hip replacement has been related to wear debris released from prosthetic components. Retrospective longterm observations of patients with the metal-on-metal prosthesis has shown long-term survivorship and good mechanical performance. Thus, the new and modified metal-on-metal prosthesis has been introduced on the market. Historical clinical data from the 1st generation metal-on-metal hip prosthesis may not be relevant for the 2nd generation of metal-on-metal hip prosthesis. Therefore, preclinical testing of the prosthesis must be conducted before clinical evaluation. We assessed the tribological performance of the metal-on-metal prosthesis versus the metal-on-polyethylene prosthesis introduced on the market as Metasul and Protasul, respectively. In a 12-channel joint simulator, 6 metal-on-metal bearing and 3 metal on polyethylene prostheses were tested, with the same number of corresponding soak controls. The wear was assessed gravimetrically. The "steady-state" wear-rates from the metal-on-metal prosthesis were almost 100 times less than that from the metal-on-polyethylene prosthesis. The tribological wear performance of the metal-on-metal hip prosthetic system is promising.

Hip Prosthesis↗
PubMed1991

[Indications of prosthesis in the treatment of knee diseases].

Hinge prostheses of the knee expose to so many local or even systemic complications that they should be used only for reconstruction of the knee after tumoral excision. In all other indications, prosthesis of the knee must be semi-constrained or non-constrained. Moreover, it seems that it would be useful to choose the prosthesis that preserves the ligaments to the best, in order to reduce as much as possible the stress imposed on bone/prosthesis interfaces and to limit the size of the prosthesis that preserves the ligaments to the best, in order to reduce as much as possible the stress imposed on bone/prosthesis interfaces and to limit the size of the prosthesis on which depends the amount of bone removed and the risk of septic complications. In rheumatic diseases prosthesis of the knee is the only sensible surgical treatment. Since the inflammatory process involves all three compartments of the knee, the prosthesis must be of the three-compartment type. In degenerative (gonarthrosis) and post-traumatic diseases of the knee, prosthesis is needed only when conservative surgery (osteotomy for realignment or malunion) is inadequate, with global femorotibial or femoropatellar involvement and major laxity of the ligaments. In global femorotibial diseases the prosthesis utilized can only be three-compartmental; in one-compartment femorotibial diseases, one-compartment prosthesis is rational if there is no lesion of the capsule and ligaments. When anatomical conditions are still compatible with conservative surgery, prosthetic surgery will be preferred only when the patient's general condition requires prompt resumption of walking.(ABSTRACT TRUNCATED AT 250 WORDS)

Arthritis, Rheumatoid↗
PubMed1994

[Hip prosthesis infection: diagnostic approach and treatment of 27 cases].

BACKGROUND: Preoperative diagnosis of hip prosthesis infection (HPI) is difficult. There is no therapeutic option which is completely effective and without risk. The aim of this study was to evaluate a diagnostic approach and therapeutic strategy in a group of patients with HPI. PATIENTS AND METHODS: A retrospective study of 27 episodes of HPI diagnosed by anatomopathologic and/or microbiologic examination of surgical samples was performed. RESULTS: Twenty-three patients with 27 episodes of HPI out of a total of 24 hip prosthesis (HP) were treated. The infection was early in 15 episodes. The etiologic agents were plasmocoagulase negative staphylococcus (NSP) in 11 cases, P. aeruginosa in 8, S. aureus in 5, Enterococcus sp. in 2 and miscellaneous in the remaining cases. In 2 cases the infection was polymycrobial. Following a mean follow period of 22.6 +/- 15.2 months, 13 out of the 14 patients in whom the prosthesis was withdrawn were cured (in 4 a second prosthesis was implanted), one out of 6 in those in whom the prosthesis remained in situ following debridement, and 2 out of 3 episodes in whom reimplantation was performed over time. The withdrawal of the prosthesis was significantly greater than debridement in the treatment of early infection (p < 0.001). The total mean length of postoperative antibiotherapy was 48.2 +/- 17 days. No differences were observed in the oral versus parenteral treatment (p = 0.22), and nor was prognosis worse in those treated for less than 42 days. CONCLUSIONS: The authors' experience suggests that attempts to save a hip prosthesis in early infection usually fail. In addition to prosthesis withdrawal or implantation of another prosthesis, six weeks of postoperative antibiotic therapy, which may be oral route, appear to be sufficient.

Aged↗
PubMed2003

Diagnosis, treatment and prevention of penile prosthesis infection.

The implantation of inflatable penile prostheses for the treatment of erectile dysfunction continues to be widely practiced in the United States and internationally. As third-line therapy for erectile dysfunction, the numbers of implants continue to rise as the population of men treated for erectile dysfunction increases. Complications of penile prosthesis implantation continued to decline as mechanical malfunctions have decreased as a result of re-engineering inflatable penile prostheses. Inflatable penile prostheses from both available vendors continue to be reliable, effective methods for restoring erectile function with high satisfaction rates. The most troublesome complication of these prostheses, however, is not mechanical but rather that of prosthesis infection. Prosthesis infections may result in further surgery, loss of penile tissue, and even the inability to replace penile prosthesis. While standard sterile technique perioperative antibiotics and careful surgical procedures continue to be the cornerstone of penile prosthesis infection avoidance, newer designs of penile prostheses for antibiotic coating have resulted in an improvement in the prevalence and incidents of penile prosthesis infection. For those patients in whom penile prostheses become infected despite adequate prophylaxis, newer techniques of salvage have demonstrated increasing success. Once and still the most dreaded complication of penile prosthesis implantation, prothesis infections can now be avoided by perioperative preparation and antibiotics as well as antibiotic-coated penile prostheses. Treatment of penile prosthesis infections once associated with severe loss of function can often be successful with modern salvage techniques. Implanting urologists must be familiar prophylaxis, avoidance, and treatment of penile prosthesis infections.

Anti-Bacterial Agents↗
PubMed2005

[Penile prosthesis. Quality outcomes and morbidity].

OBJECTIVES: To study patient satisfaction and complications appeared in a series of patients with erectile dysfunction undergoing implant of penile prosthesis. METHODS: Retrospective study of all patients undergoing surgical treatment for erectile dysfunction by penile prosthesis implant between 1993 and 2003. Collected data included patient age at the time of surgery, previous treatment, and significant medical history. We reviewed the models of prosthesis employed, incisions, and complications appeared. Finally, a questionnaire was elaborated to establish the level of patient satisfaction. RESULTS: 24 prostheses were implanted between 1993 and 2003. Mean patient age was 56.6 +/- 7.56 years (36-63), median 59.5 yr. Penile-scrotal incision was employed in 13 (54.16%) patients, suprapubic incision in 6 (25%) and subcoronal incision in 1 (4.16%). Type of prosthesis: semirrigid AMS 600 9 (37.5%), semirrigid AMS 650 10 (41.66%); the two component hydraulic prosthesis AMS Ambicor was used only in one case. Six (25%) patients presented complications. 16.66% were minor, cavernositis, pain, hematoma or prosthesis extrusion. Prosthesis extraction was necessary in 2 (8.33%) cases. 13 (54.16%) patients responded to the telephone survey 85% of them use their prosthesis. 54% percent refer adequate self-satisfaction and partner satisfaction (well satisfied/much satisfaction). 23% not too bad, and the remainder 23% bad or very bad. CONCLUSIONS: Despite the highest rate of postoperative complications, penile prosthesis is adequately accepted by patients with erectile dysfunction, even malleable models. Patient satisfaction is high, being higher in partners. Most patients would desire to undergo surgery again if they were in the same situation.

Humans↗
PubMed2002

Tissue reaction following the implantation of a DALLON H vascular prosthesis in the thoracic aorta defect. Experimental tests.

Vascular prostheses made of polyester or polytetrafluoroethylene fibres are most frequently used nowadays. Woven polyester prostheses are sealed following the suturing in the circulatory system, but they cause a tissue reaction. Knitted polyesters grafts cause a lesser tissue reaction, but demand intraoperative sealing. Thus numerous tests to improve them are conducted. TRICOMED S.A. (Poland) has modified the company's own double velour knitted vascular prosthesis. The graft's physical and chemical features have been changed and hydrophilia has been used, due to which dripping the graft takes little blood and its tightness is achieved in a dozen or so seconds. The evaluation of surgical qualities as well as the healing-in process of the modified knitted hydrophilic prosthesis DALLON H has been conducted at the Department of Experimental Surgery and Biomaterials of Wrocław Medical University. DALLON H prosthesis was compared to DALLON, a standard double velour knitted prosthesis. The tests were performed on 16 Polish breed piglets with 25-35 kg of weight and 2.5 months of age. Two follow-up periods of 3 and 6 months were established following the surgeries. In each group six piglets had a 6-cm-long segment of DALLON H prosthesis sutured in the thoracic aorta defect, whereas two piglets received a 6-cm-long segment of DALLON prosthesis. The evaluation of surgical qualities of both kinds of grafts was performed intraoperatively. The main emphasis was put on the conditions in which the grafts became tight and the way they were handled during the aortal anastomosis. After 3 and 6 months the animals were autopsied. A macroscopic analysis of the incurred preparations was performed. Roent-genograms of the thoracic aorta sections replaced by the grafts were made in order to establish the shape of their lumen and present calcium salt deposits in their region. Light microscopic tests were performed by dying the preparations with hematoxiline and eosine to differentiate tissues and basic morphotic elements; using the van Giesen method, in order to reveal collagenous fibres; using the Weigert method to reveal elastic fibres, and using the Koess method to reveal calcium salt deposits. An ultrastructural evaluation of the internal surface of the grafted vascular sections was performed by a scanning electron microscope. In view of the experimental tests performed it has been established that DALLON H prosthesis used in vascular surgical procedures is not difficult and the prosthesis can be handled in the same way as some other knitted vascular prostheses. DALLON H does not need preclotting and when the blood flow has been restored through the grafted section the prosthesis immediately becomes completely tight. In view of the tests performed no differences in the healing-in process between the modified DALLON H and DALLON prostheses were observed.

Anastomosis, Surgical↗
PubMed1995

The gelweave polyester arterial prosthesis.

OBJECTIVE: To determine the effect of the gelatin coating on the efficacy of Gelweave, a new gelatin-sealed woven polyester graft material, as an arterial prosthesis. DESIGN: In-vitro and in-vivo studies of the prosthesis. SETTING: A laboratory of experimental surgery in a university teaching institution. SUBJECTS: After in-vitro testing of the material, eight dogs were subjected to a series of in-vivo tests to evaluate the properties of Gelweave in comparison with its unsealed precursor and a commerically available collagen-coated woven polyester prosthesis. INTERVENTION: Implantation of the prosthesis as a thoracoabdominal bypass for prescheduled periods ranging from 4 hours to 6 months. MAIN OUTCOME MEASURES: Physical and chemical properties of the virgin prosthesis compared with the other two prostheses, effects of the gelatin-sealed prosthesis on healing, the hematologic characteristics of the dogs before operation and at sacrifice, microscopic studies, fibrin and platelet uptakes, prostaglandin secretion, and properties of the Gelweave grafts removed at varying periods after implantation. RESULTS: The gelatin sealant in the Gelweave prosthesis effectively reduced the water permeability of the new prototype to zero. Neither blood loss at implantation nor infection during the postimplantation period was observed. The gelatin impregnation did not cause any adverse response in the dogs and was completely lysed within 2 weeks, thus allowing encapsulation and graft healing to progress satisfactorily. After 2 weeks, the prostacyclin:thromboxane ratio was greater than 1.0, whereas the fibrin and platelet uptakes on the luminal surface of the Gelweave grafts remained low, regardless of the period of implantation. Analysis of the explanted grafts confirmed that this gelatin-sealed prototype prosthesis healed satisfactorily and no adverse biologic response occurred as a result of the gelatin coating. It maintained its biostability during 6 months in situ. CONCLUSION: The new Gelweave arterial prosthesis is ready for clinical use as a thoracic and abdominal vascular substitute.

Animals↗
PubMed1994

The Angelchik antireflux prosthesis: long-term clinical and technical follow-up.

OBJECTIVE: To evaluate the long-term clinical outcome and compare the rupture rate of the two generations of the silicone Angelchik antireflux prosthesis. DESIGN: A cohort study. Follow-up ranged from 61 to 119 months. SETTING: A university teaching hospital. PATIENTS: Sixty-three patients: 33 patients received the first generation Angelchik device (group 1) and 30 patients received a second generation design (group 2). The two groups were comparable for sex ratio, mean age and duration of symptoms. INTERVENTIONS: Implantation of the Angelchik prosthesis. MAIN OUTCOME MEASURES: Comparison of the rupture rate and migration of the prosthesis as assessed by patient questionnaire, telephone interview and radiography of the abdomen. RESULTS: The prosthesis remained in a good position in 53% of group 1 patients and 93% of group 2 patients. The prosthesis was removed in 40% of group 1 patients, most often for rupture, and in only 7% of patients in group 2, to relieve dysphagia (p < 0.01). Grading on a Visick scale demonstrated a good result in 37% of group 1 patients and 69% of group 2 patients. Long-term dysphagia was the most prevalent adverse effect, seen in 45% of patients whose prosthesis was in a good position, and symptomatic reflux recurred in 8%. CONCLUSIONS: The second generation of the Angelchik prosthesis, resulted in a reduced rupture rate of the prosthesis. Nevertheless the high complication and the failure rates militate against continued implantation of the prosthesis.

Adult↗